Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02823574 · OUTCOME

ORR - Platinum Eligible Subgroup Based on PD-L1 Expression

Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-05-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to end of study. Approximately 63 Months

What was measured

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Analysis population: Platinum Eligible Subgroup

Groups in this outcome

Treatment A - Platinum Eligible Subgroup

Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

Treatment B - Platinum Eligible Subgroup

Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup123
Treatment B - Platinum Eligible Subgroup61

Reported measurements

<1%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup51
Treatment B - Platinum Eligible Subgroup23
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup15.7Not reported7.028.6Not reported
Treatment B - Platinum Eligible Subgroup21.7Not reported7.543.7Not reported
PD-L1: ≥ 1%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup65
Treatment B - Platinum Eligible Subgroup33
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup21.5Not reported12.333.5Not reported
Treatment B - Platinum Eligible Subgroup30.3Not reported15.648.7Not reported
PD-L1: < 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup87
Treatment B - Platinum Eligible Subgroup37
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup14.9Not reported8.224.2Not reported
Treatment B - Platinum Eligible Subgroup24.3Not reported11.841.2Not reported
PD-L1: ≥ 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup29
Treatment B - Platinum Eligible Subgroup19
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup31.0Not reported15.350.8Not reported
Treatment B - Platinum Eligible Subgroup31.6Not reported12.656.6Not reported
PD-L1: <50%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup96
Treatment B - Platinum Eligible Subgroup41
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup16.7Not reported9.825.6Not reported
Treatment B - Platinum Eligible Subgroup24.4Not reported12.440.3Not reported
PD-L1: > 50%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup20
Treatment B - Platinum Eligible Subgroup15
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup30.0Not reported11.954.3Not reported
Treatment B - Platinum Eligible Subgroup33.3Not reported11.861.6Not reported
PD-L1: 1 - < 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup36
Treatment B - Platinum Eligible Subgroup14
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup13.9Not reported4.729.5Not reported
Treatment B - Platinum Eligible Subgroup28.6Not reported8.458.1Not reported
Without quantifiable PD-L1 expression at baseline

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup7
Treatment B - Platinum Eligible Subgroup5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible SubgroupNANot reportedNANANot reported when sample size is less than 10 subjects for the subgroup category,CI not calculable
Treatment B - Platinum Eligible SubgroupNANot reportedNANANot reported when sample size is less than 10 subjects for the subgroup category, CI not calculable
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.0
        upper Limit
        28.6
        value
        15.7
      2. group Id
        OG001
        lower Limit
        7.5
        upper Limit
        43.7
        value
        21.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    <1%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.3
        upper Limit
        33.5
        value
        21.5
      2. group Id
        OG001
        lower Limit
        15.6
        upper Limit
        48.7
        value
        30.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        33
      units
      Participants
    title
    PD-L1: ≥ 1%
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.2
        upper Limit
        24.2
        value
        14.9
      2. group Id
        OG001
        lower Limit
        11.8
        upper Limit
        41.2
        value
        24.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        87
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    PD-L1: < 25%
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.3
        upper Limit
        50.8
        value
        31.0
      2. group Id
        OG001
        lower Limit
        12.6
        upper Limit
        56.6
        value
        31.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        19
      units
      Participants
    title
    PD-L1: ≥ 25%
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.8
        upper Limit
        25.6
        value
        16.7
      2. group Id
        OG001
        lower Limit
        12.4
        upper Limit
        40.3
        value
        24.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      2. group Id
        OG001
        value
        41
      units
      Participants
    title
    PD-L1: <50%
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.9
        upper Limit
        54.3
        value
        30.0
      2. group Id
        OG001
        lower Limit
        11.8
        upper Limit
        61.6
        value
        33.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        15
      units
      Participants
    title
    PD-L1: > 50%
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.7
        upper Limit
        29.5
        value
        13.9
      2. group Id
        OG001
        lower Limit
        8.4
        upper Limit
        58.1
        value
        28.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    PD-L1: 1 - < 25%
  8. categories
    1. measurements
      1. comment
        Not reported when sample size is less than 10 subjects for the subgroup category,CI not calculable
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Not reported when sample size is less than 10 subjects for the subgroup category, CI not calculable
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Without quantifiable PD-L1 expression at baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      123
    2. group Id
      OG001
      value
      61
    units
    Participants
description
ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
    id
    OG000
    title
    Treatment A - Platinum Eligible Subgroup
  2. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
    id
    OG001
    title
    Treatment B - Platinum Eligible Subgroup
param Type
NUMBER
population Description
Platinum Eligible Subgroup
reporting Status
POSTED
time Frame
From randomization to end of study. Approximately 63 Months
title
ORR - Platinum Eligible Subgroup Based on PD-L1 Expression
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice